Chlorpromazine Hydrochloride
Chlorpromazine Hydrochloride Injection, USP
Approved
Approval ID
d37a4c21-b503-4791-a4d0-2ccc8891d88e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Mar 14, 2024
Manufacturers
FDA
Zydus Lifesciences Limited
DUNS: 918596198
Products 2
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Chlorpromazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1779
Application NumberANDA217275
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorpromazine Hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateMarch 14, 2024
FDA Product Classification
INGREDIENTS (6)
SODIUM METABISULFITEInactive
Quantity: 1 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
CHLORPROMAZINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 mL
Code: 9WP59609J6
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 6 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
ASCORBIC ACIDInactive
Quantity: 2 mg in 1 mL
Code: PQ6CK8PD0R
Classification: IACT
SODIUM SULFITEInactive
Quantity: 1 mg in 1 mL
Code: VTK01UQK3G
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Chlorpromazine Hydrochloride
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code70771-1778
Application NumberANDA217275
Product Classification
M
Marketing Category
C73584
G
Generic Name
Chlorpromazine Hydrochloride
Product Specifications
Route of AdministrationINTRAMUSCULAR
Effective DateMarch 14, 2024
FDA Product Classification
INGREDIENTS (6)
ASCORBIC ACIDInactive
Quantity: 2 mg in 1 mL
Code: PQ6CK8PD0R
Classification: IACT
SODIUM SULFITEInactive
Quantity: 1 mg in 1 mL
Code: VTK01UQK3G
Classification: IACT
CHLORPROMAZINE HYDROCHLORIDEActive
Quantity: 25 mg in 1 mL
Code: 9WP59609J6
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 6 mg in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM METABISULFITEInactive
Quantity: 1 mg in 1 mL
Code: 4VON5FNS3C
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
LOINC: 51945-4Updated: 3/14/2024
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
NDC 70771-1778-1
chlorproMAZINE Hydrochloride Injection, USP
25 mg/mL
For Deep Intramuscular Use
Discard unused portion
1 mL Single-Dose Vial
Rx only
NDC 70771-1778-7
chlorproMAZINE Hydrochloride Injection, USP
25 mg/mL
For Deep Intramuscular Use
Discard unused portion
25 x 1 mL Single-Dose Vial
Rx only
SPL UNCLASSIFIED SECTION
LOINC: 42229-5Updated: 3/14/2024